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FDA grants priority review to Halaven for advanced soft tissue sarcoma
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The FDA granted priority review to eribulin mesylate for patients with inoperable leiomyosarcoma and liposarcoma who have previously received chemotherapy for advanced or metastatic disease, according to a press release from the drug’s manufacturer.
Eribulin mesylate (Halaven, Eisai) — a microtubule dynamics inhibitor — is indicated for patients with metastatic breast cancer who have received two or more chemotherapeutic regimens for metastatic disease, and whose prior treatment included an anthracycline and a taxane in the adjuvant or metastatic setting.
In vitro studies demonstrated eribulin mesylate leads to apoptotic cell death after prolonged and irreversible mitotic blockage using a tubulin-based antimitotic mechanism.
With more than 50 subtypes of soft tissue sarcomas — which account for less than 1% of all malignant tumors — clinicians are faced with unique clinical, prognostic and therapeutic challenges when treating patients in this setting.
“Advanced soft tissue sarcoma is very difficult to treat, so we are excited to be one step closer to potentially bringing an additional treatment option to patients in need,” Kenichi Nomoto, PhD, president of the oncology production creation unit at Eisai, said in the release.